Prescription medications are effective remedies for many patients when taken according to instructions. However, studies have shown that, on average, about 50% of patients do not comply with the prescribed medication regimens. A low rate of compliance with medication regimens results in a large number of hospitalizations and admissions to nursing homes every year. Consequently, various methods and apparatus have been made available to improve patient compliance with prescribed regimens in efforts to improve patient health.
There are many complex reasons why patients do not comply with their medication regimens. However, one major reason relates to memory. A large number of persons who take medications, particularly those over 65 years of age, fail to comply with a prescribed regimen because of one or more of the following: (1) forgetting to take a medication, (2) forgetting to take a medication at the correct time, (3) forgetting the correct dosage, (4) forgetting important warnings and instructions that accompany the medications, (5) forgetting to refill a prescription, (6) forgetting to perform a health-related activity such as a therapeutic exercise or pulse reading, or (7) forgetting to attend their next doctor's appointment.
There is thus a need in the prior art for improved methods and apparatus for assisting a patient's memory with respect to timing, dosage, and counseling information relating to prescribed medications, as well as with respect to refilling prescriptions therefor, performing various activities or keeping a doctor's appointment.
Moreover, at present health care providers such as physicians, pharmacists, and nurses do not have a suitable method of determining if patients are taking their medications as prescribed. This information is important for several reasons, including: (1) assisting a health care provider in assessing whether a lack of improvement in a patient's condition is due to noncompliance or to ineffectiveness of the medication or dosage, and (2) assisting with diagnosis and counseling based on the patient's pattern of compliance (e.g., is the patient forgetting or neglecting to take medications at night only; is the patient experiencing reduced cognition from the medication; etc.).
Indirect measures of compliance such as patient interviews and pill counts are only accurate approximately half the time. Direct measures such as blood tests (to determine medication levels) are costly, inconvenient for outpatients, and may be inaccurate due to varying metabolism and other factors.
There is thus a need in the prior art to provide compliance information to health care providers in order to develop the correct intervention for the patient's illness.
New burdens for the pharmacist have been legislated by the Omnibus Budget Reconciliation Act of 1990 ("OBRA '90"). Therein, all pharmacists are required to offer medication counseling to all Medicaid patients as of Jan. 1, 1993. Subsequent to the passage of this Act, at least 41 states have expanded the counseling requirement to all patients. In addition, various states are drafting standards that meet the Federal requirements, which require the following types of information to be provided for all prescription drugs: name and description of medicine, dosage form and dosage, how to administer, duration of drug therapy, how to handle missed doses, and prescription refill information.
Accordingly, there is a need for apparatus and methods for providing information which complies with the legislation and which helps the patient remember the information after leaving the pharmacy.
Moreover, it is difficult for the verbal counseling sessions to achieve their goals because patients often forget all or part of the message soon after the session is completed.
There is thus a need in the prior art for a device or method of repeating a counseling session for a patient, wherein the counseling information is repeated at the patient's convenience.
There is a more specific need to provide a "counseling message" that the user can access on the user device at any arbitrary time, as long as another message is not being played. A corollary need is for an ability to limit the number of times a counseling message can be repeated within a predetermined period of time in order to conserve power. A related need is to allow the counseling message to be programmed to play automatically at particular times and days.
The prior art discloses a number of devices that use electronic technology to remind users when to take their medication. These devices generally can be classified as:
(1) electronic timers/alarms,
(2) medication dispensers combined with alarms, and
(3) fixtures for holding medication containers which are combined with alarms.
As described in the following summary, most of the prior art requires the users to program the device themselves. A few references disclose methods that allow a pharmacist or another person to provide some level of programming. However, the prior art fails to provide devices meeting the above noted and long felt needs. The present invention thus provides new and improved features and methods which meet the above described needs, which overcome the deficiencies of the prior art, which can best monitor and improve health care compliance and which will provide increased acceptance of electronic reminder systems and dispensers by patients and health care providers.
Prior art in electronic timers and alarms for medication compliance, such as U.S. Pat. No. 5,200,891, typically require the user to program the device by using a variety of switches and buttons. The small buttons are difficult for elderly persons to operate, and it is both complex and intimidating for many patients, especially the elderly, to remember the sequence of operations and meaning of the buttons; even with the aid of text prompts on an LCD as provided in U.S. Pat. No. 4,558,303. Furthermore, it is left up to the patient to remember to reprogram the device every time the regimen changes and to do so accurately. U.S. Pat. No. 5,088,056 requires the user to operate a multiple mode switch depending on whether the medication is being taken as scheduled, ahead of schedule, or as needed. The added functionality thus results in added complexity, and discouragement, for the user.
There is thus a need in the prior art for medication reminders which do not require patient operated reprogramming, and which permit regimen programming by a health care provider.
Furthermore, total reliance on text messages, as described in U.S. Pat. Nos. 4,725,997, and 5,157,640, causes problems for the elderly, for users with low literacy skills, and for persons who are visually impaired. Such problems may arise because of glare from the LCD used therein or from the relatively small type size required for such "portable" devices. If the display size is increased to improve readability, then the reminder device becomes larger and less portable. In any case, the amount and type of information that can be communicated in text format at one time in a practical device is limited.
Medication reminder messages that are generated by speech synthesizers rather than LCDs or printed text are suggested in U.S. Pat. Nos. 5,088,056, 4,768,176, and 5,200,891. However, speech synthesis produces a "robotic" sounding voice that frequently is difficult for people to understand, particularly for the elderly, and which may discourage continued use of the device. Such difficulty in understanding is especially likely when complex words such as medication names are spoken. Presbycusis (i.e., age related hearing degradation) makes the task of distinguishing medication names even more difficult, especially when necessary to distinguish among names that sound alike or names that have higher frequency components. Research indicates that presbycusis is a widespread condition among the elderly population.
There is thus a need in the prior art for medication reminders which generate clear and natural sounding voice messages which are more easily communicated, more easily perceived, more flexibly changed, and more easily remembered than messages communicated through visual displays and alarms.
Research has shown that patients are not interested in a device that could potentially generate an audible tone or voice message in a public place or at a social gathering, because of a consideration that such medication information is private and confidential, and because of embarrassment upon public disclosure of the same. U.S. Pat. No. 5,200,891 addresses this issue by providing a "no-bell" button that suspends the audible tone for a predetermined period of time. The addition of another button on the surface of the device to perform this function further complicates its operation, however, and allows time to pass without informing the user that a medication needs to be taken.
There is thus a need in the prior art for medication reminder devices which have a capability for alerting the user at all scheduled times, such as by generating an audible or visual alert, which produce the voice messages only on demand by the user, and which produce the voice messages and any audible alert at a volume level selectable by the user.
Because of differences in age, state of health, weight, other medications being taken, and other factors, the instructions for two patients taking the same medication may vary considerably. Therefore, a system that relies only on fixed voice messages that are stored in a ROM (e.g., U.S. Pat. No. 5,088,056) may be very limited in applicability to the general population. Moreover, while some prior art devices are alleged to be portable, as more features are added to a reminder device, the power consumption, weight and size of the device increases. For example, a device disclosed in U.S. Pat. No. 5,088,056 must be plugged into an electrical outlet.
There is thus a need in the prior art for a device capable of generating a variety of customized reminder messages for any user for any medication, and for a device of sufficiently small size and weight as to be truly portable, having minimized power consumption.
In the prior art, medication reminders produce a fixed means of communicating with users. However, research has shown that different users have different cognitive abilities, and thus require different methods of communication. For example, some people prefer fast and concise voice messages to avoid loss of interest in and attention to the message content. Others require slower messages, with more words and pauses needed to comprehend the details. Cognitive skills and needs change over time and, in some elderly users, in response to use of certain medications that affect cognition. Such differences in cognitive ability and needs are not recognized by the prior art.
Thus, there is a need in the prior art for medication reminder devices which provide reminder messages tailored to the individual user, and which provide adaptive messages corresponding to particular situations, such as playing out but failing to confirm a particular reminder message, skipping of too many doses, or repeating of messages an excessive number of times. There is yet another need in the art to permit a health care provider to develop different message constructions to accommodate users with different cognitive skills, users whose cognitive skills decline, and users who become more proficient as they gain experience with the device.
There is still a further need in the prior art to provide a medication reminder device including logic for switching between one type of message construction and another, either adaptively or based on a predetermined schedule. Similarly, there is a need in the prior art for providing an adaptive volume control which increases the volume of a prompt and the generated message each time a user does not respond to a prompt or a message.
In the prior art, such as U.S. Pat. No. 4,258,354, audible and visual prompts are provided to remind the user about a medication to be taken. However, the art fails to recognize a large number of ways in which users may be interrupted in performing their tasks, such as by a telephone ring, a doorbell, another person talking, etc. These common interruptions are likely to arise occasionally at the time an audible prompt or a voice message is being played. The prior art fails to provide either a method or an apparatus to assist people who, for whatever reason, do not hear an audible prompt or miss some or all of a reminder message.
Thus, there is a need in the prior art for a medication reminder capable of repeating each segment of a message on demand one or more times, so that the user is confident that the entire message is understood. Along with such a needed capability, there is a related need to permit the health care provider to place a limit on the number of repeats for each message segment, to reduce power consumption.
In the prior art, several approaches are taken when the user does not respond to the prompting means. In some instances, such as in U.S. Pat. No. 5,157,640, the audible prompts continue indefinitely until the user responds. Other descriptions recognize that a continuous alarm that is turned off only when the user responds may consume too much power. Therefore, some prior art patents give the user one opportunity to respond to the alarm and then discontinue the audible prompt, while others repeat the audible prompt periodically, such as every 5 minutes (U.S. Pat. No. 4,768,177) or every 5 seconds (U.S. Pat. No. 5,157,640) for a certain period of time such as ten minutes. While these and other devices will leave an LCD message or LED indicator on to alert the user that a medication needs to be taken, more information is needed by the user. In particular, while a device as disclosed in U.S. Patent 4,558,303 discloses avoiding overdosing by instructing a user not to take a dose with too little time remaining to the next dose, a user should receive more detailed instructions upon belatedly remembering to take a medication dosage close to the time of the next scheduled dosage. In such a situation, it is possible that one or more medication messages may become "outdated" because it is too close to the next dosage to take the medication, or it is time for the next medication as the dosage has been missed. It is usually unclear to the user whether to (1) skip that dose and wait for the next scheduled dose, (2) take the dose and also take the next scheduled dose, or (3) skip the dose but take a double dose at the next scheduled time.
There is thus a need in the art for a medication reminder device which informs the user in detail on the course of action to be taken in connection with a dosage being taken at other than a prescribed time.
Further, in some circumstances a patient is prescribed different medications that are to be taken at the same time. U.S. Pat. No. 5,157,640 establishes a queue of prompts and "uncovers" the next message in the queue after the user acknowledges the preceding beep. As previously noted, a problem arises when the user does not take a medication at the prescribed time.
One approach to resolving this problem is to specify a time interval within which the patient is allowed to take a medication and have it be effective. U.S. Pat. No. 4,725,997 refers to a "deviation window" and proposes to adjust the time interval between doses, and/or adjust the size of the dose to maintain an acceptable drug level in the patient. Such an approach could be very confusing to the patient in view of changes in the regimen on one or several days.
There is thus a need in the prior art for a medication reminder device and method which simplifies compliance for a user, and which only prompts a user to take a medication during the pharmaceutically correct time interval. More particularly, there is a need for a device incorporating logic and information which only prompts a user to take a medication within a predetermined "maximum effective time" (MET), and then stops prompting the user until the next scheduled dosing time. Thus, there is a need for a device capable of removing a message from a message queue when the MET of the associated medication has expired. There is an associated need to provide a medication reminder device which is capable of modifying the next scheduled message, after a medication dosage was missed, as and when new instructions are needed (e.g., "take 2 pills this time").
Moreover, to attend to situations wherein a plurality of medications are prescribed for substantially the same time, there is a need in the prior art for a device having an ability to provide, in a sequential fashion, prompts and messages that are scheduled for the same time of day, with a prompt and message being issued only after the preceding message has been issued and acted upon by either the user or the device.
Further, there are instances when a medication reminder may be in one location but the user may be in another, such as in two separate rooms, or when the level of background noise, such as a television, is sufficiently high that the audible prompt is not heard. To enable the user to take the required medications as close as possible to the prescribed time, it would be useful to have a supplemental way of communicating with the user that enhances the value of the user device.
Thus, there is a need in the prior art for a small, lightweight "satellite" device, which can nearly always be on the user's person or in the user's vicinity and which provides a prompting signal to alert the user to access a complete voice message from the "base station" user device.
U.S. Pat. No. 5,200,891 discloses interfaces between a prompting medication dispensing device and a variety of health care devices, such as pulse monitors, thermometers, blood pressure monitors and the like. The data are printed out, displayed, and entered into a memory. However, the user is not instructed on when to take the readings or what to do with the results.
Accordingly, there is a need in the prior art for a device to generate voice messages to remind the user to monitor temperature, pulse, blood pressure, etc.
There is still a further need to generate messages for guiding a user on taking specific actions with data that is transferred from external monitoring devices to the user device, such as "take a second reading", "call Dr. Smith", etc.